[Hiring] Project Coordinator @Indero

Role Description

The Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team, and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Project Coordinator, you will take the lead to ensure timeframes, targets, and the quality of the deliverables are in line with internal and external customer expectations.

This role is perfect for you if:

• You have experience in project administration and clinical research;
• You want to work in a collaborative environment;
• You want to have an impact in a fast-growing company.

Responsibilities

• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Establish site activation timelines with selected sites and coordinate activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up.
• Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalate to the Project Manager risks to site activation schedule.
• Communicate directly with the study teams and external site staff to ensure tasks and priorities are aligned to the defined study timelines.
• Collect, review, and file sites' essential documents.
• Ensure essential documentation is complete and of good quality to successfully pass review for site activation.
• Ensure that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collect and distribute documents from/to sites.
• Produce meeting minutes from project meetings.
• Maintain ADI log.
• Assign documents for internal project-specific training and coordinate training reconciliation and documentation.
• May assist with drafting of study documents and study plans for clinical trials.
• Act as a main point of contact for all site correspondences for non-protocol related issues.
• Assist sites with local ethics submissions.
• Assist internal and external teams with access to study-specific systems.
• Assist with initiating and maintaining study files.
• Assist with assembling and shipping the Investigator’s Study File.
• Maintain project timeline dates, enrolment tracking tools, and study material inventory.
• Prepare shipments of study supplies to clinical sites, when applicable.
• Assist with preparation of Investigators’ Meeting.
• Distribute study correspondence to sites.
• Serve as in-house contact to support CRAs when traveling.
• Review and reconcile investigators' site and vendor payments.
• Assist with project tracking activities and status reports preparation.
• Participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for project related issues.
• May perform project management duties on designated trials.

Qualifications

• Bachelor’s degree in a field relevant to clinical research or equivalent experience;
• Specialized graduate diploma in drug development is an asset;
• Experience in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry, an asset;
• Excellent oral and written skills in English; French is an asset;
• Excellent knowledge and competency in Word, Excel, and PowerPoint;
• Ability to prioritize different assignments and work under pressure;
• Attention to detail and meet timelines;
• Quick learner, good adaptability, and versatile;
• Strong organizational, communication, problem-solving, and multi-tasking skills.

Benefits

• Flexible work schedule;
• Home-based position;
• Ongoing learning and development.

Company Description

Indero is a CRO specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Argentina.